Study on Meldonium and Physical Activity for Patients with Heart Failure with Preserved Ejection Fraction

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Meldonium and personalized physical activities in patients with a condition known as Chronic Heart Failure with Preserved Ejection Fraction. Heart failure is a condition where the heart doesn’t pump blood as well as it should, and in this specific type, the heart’s ability to pump blood is preserved, but it still doesn’t function properly. Meldonium is a medication that will be given in capsule form, and the study will also include recommendations for physical activities tailored to each individual.

The purpose of the study is to evaluate how effective Meldonium and personalized physical activities are in treating patients with this type of heart failure. Participants will receive Meldonium and follow a personalized physical activity plan. The study will observe changes in how well participants can tolerate physical activity, which will be assessed through a test that measures how much oxygen the body uses during exercise.

The study will take place over a period of time, and participants will be monitored to see how their condition responds to the treatment. The goal is to understand if Meldonium, along with individualized physical activities, can improve the health and quality of life for people living with chronic heart failure with preserved ejection fraction.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. These include having chronic heart failure classified as NYHA class II or III, a left ventricle ejection fraction greater than 50%, and having received optimal medical therapy for at least three months.

A coronary angiography or computed coronary angiography must have been performed to rule out obstructive coronary artery disease. Participants must be 18 years or older.

2 medication administration

The medication used in the trial is meldonium, administered orally. The dosage, frequency, and duration of administration are determined by the study protocol and communicated to participants at the start of the trial.

3 physical activity recommendations

Participants receive individualized physical activity recommendations. These activities are tailored to each participant’s condition and are designed to improve heart function and overall health.

4 monitoring and assessments

Throughout the trial, participants undergo regular monitoring and assessments to evaluate the effectiveness of the treatment. This includes measuring changes in physical activity tolerance using a cardiopulmonary test, which assesses the relative maximal oxygen uptake (VO2 max).

5 completion of the trial

The trial is estimated to conclude by December 1, 2029. Participants will be informed of the outcomes and any further steps at the end of the study.

Who Can Join the Study?

The patient must have chronic heart failure with a II – III functional class according to the NYHA (The New York Heart Association). This means the patient has heart failure that affects their daily activities to a moderate or severe degree.
The patient must have had a transthoracic echocardiography test, which is an ultrasound of the heart, showing a left ventricle ejection fraction greater than 50%. This test measures how well the heart is pumping blood.
The patient must have a left atrial volume index (LAVI) greater than 34 ml/m². This is a measurement related to the size of one of the heart’s chambers.
The patient must have been receiving optimal medical therapy for at least 3 months. This means they are on the best possible treatment for their heart condition.
The patient must have had a coronary angiography or a computed coronary angiography to ensure they do not have obstructive coronary artery disease. These are tests to check for blockages in the heart’s blood vessels.
The patient must be 18 years or older.
Both male and female patients are eligible to participate.

Who Cannot Join the Study?

Patients who have a different type of heart failure than the one being studied.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study’s physical activity recommendations.
Patients who have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to give informed consent, which means they cannot fully understand and agree to the study’s requirements.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Pauls Stradins Clinical University Hospital	Riga	Latvia

Trial status

Country	Status	Recruitment Start
Latvia	Recruiting	26.02.2024

Trial locations

Investigated drugs:

Meldonium

Meldonium is a medication used in this trial to help improve heart function in patients with heart failure. It works by increasing blood flow and oxygen to the heart, which can help the heart work more efficiently and reduce symptoms of heart failure.

Individualized Physical Activities are tailored exercise programs designed specifically for each patient in the trial. These activities aim to improve overall heart health and physical fitness, helping patients manage their heart failure symptoms better. The exercises are chosen based on the patient’s health status and capabilities to ensure safety and effectiveness.

Investigated diseases:

Chronic heart failure with preserved ejection fraction – This condition occurs when the heart’s lower chambers are unable to fill properly with blood, despite the heart muscle contracting normally. It is characterized by symptoms such as shortness of breath, fatigue, and fluid retention. The heart’s ejection fraction, which measures the percentage of blood leaving the heart each time it contracts, remains normal or near normal. Over time, the heart’s ability to pump blood effectively may worsen, leading to increased symptoms. Patients may experience difficulty in performing physical activities due to reduced exercise tolerance. The condition is often associated with other health issues like high blood pressure and diabetes.

Trial ID:

2023-509804-14-00

Protocol code:

MELD-PHYS-2023

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Meldonium and Physical Activity for Patients with Heart Failure with Preserved Ejection Fraction

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?